Ignite Creation Date:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2026-01-03 @ 9:15 PM
Study NCT ID:
NCT03134768
Status:
COMPLETED
Last Update Posted:
2020-04-03
First Post:
2017-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Birth on Immunological Parameters in Cord Blood
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'elena.sandalova@danone.com', 'phone': '6568309433', 'title': 'Dr Elena Sandalova', 'organization': 'Danone Nutricia Research'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Vaginally Born Children', 'description': 'Cord blood samples collected from vaginally born children', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cytokines Profile in Cord Blood Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vaginally Born Children', 'description': 'Cord blood samples collected from vaginally born children'}], 'classes': [{'title': 'IL-6', 'categories': [{'measurements': [{'value': '1.6', 'spread': '7.1', 'groupId': 'OG000'}]}]}, {'title': 'TNFa', 'categories': [{'measurements': [{'value': '21.81', 'spread': '8.4', 'groupId': 'OG000'}]}]}, {'title': 'IL-8', 'categories': [{'measurements': [{'value': '165', 'spread': '279', 'groupId': 'OG000'}]}]}, {'title': 'G-SCF', 'categories': [{'measurements': [{'value': '14', 'spread': '44', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': 'Following cytokines will be part of the profile: IL-6, IL-1, IL-2, IL-4, IL-5, IL-7, IL-8, IL-10, IL12p70, IL-13, IL-17, G-CSF, GM-CSF, IFNg, MCP-1(MCAF), MIP-1b, TNFa', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Other cytokines were out of detection limits.'}, {'type': 'PRIMARY', 'title': 'Cord Blood Immunoglobulin Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vaginally Born Children', 'description': 'Cord blood samples collected from vaginally born children'}], 'classes': [{'title': 'IgE', 'categories': [{'measurements': [{'value': '1.7', 'spread': '2', 'groupId': 'OG000'}]}]}, {'title': 'IgG', 'categories': [{'measurements': [{'value': '2613064', 'spread': '3066008', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': 'Immunoglobulin levels will be measured in cord blood plasma', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Allergen Stimulated Cytokine Expression in the Supernatants of Cord Blood Mononuclear Cells (CBMC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vaginally Born Children', 'description': 'Cord blood samples collected from vaginally born children'}], 'classes': [{'categories': [{'measurements': [{'value': '18612', 'spread': '38892', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': 'Cellular response to allergen stimulation will be measured in supernatants of cultured cord blood mononuclear cells.', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'IL-6 was measured after incubation with House Dust mite extracts. The mean expression of IL-6 by the cord blood mononuclear cells in response to house dust mite extract is presented here.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Vaginally Born Children', 'description': 'Cord blood samples collected from vaginally born children'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': "Recruitment took place in KK Women's and Children's Hospital"}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Vaginally Born Children', 'description': 'Cord blood samples collected from vaginally born children'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'cord blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2017-10-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-01', 'studyFirstSubmitDate': '2017-04-26', 'resultsFirstSubmitDate': '2020-03-05', 'studyFirstSubmitQcDate': '2017-04-26', 'lastUpdatePostDateStruct': {'date': '2020-04-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-03-05', 'studyFirstPostDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-11-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cytokines Profile in Cord Blood Plasma', 'timeFrame': '1 year', 'description': 'Following cytokines will be part of the profile: IL-6, IL-1, IL-2, IL-4, IL-5, IL-7, IL-8, IL-10, IL12p70, IL-13, IL-17, G-CSF, GM-CSF, IFNg, MCP-1(MCAF), MIP-1b, TNFa'}, {'measure': 'Cord Blood Immunoglobulin Levels', 'timeFrame': '1 year', 'description': 'Immunoglobulin levels will be measured in cord blood plasma'}, {'measure': 'Allergen Stimulated Cytokine Expression in the Supernatants of Cord Blood Mononuclear Cells (CBMC)', 'timeFrame': '1 year', 'description': 'Cellular response to allergen stimulation will be measured in supernatants of cultured cord blood mononuclear cells.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Immunologic Activity Alteration']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to understand the immediate effect of birth on immunological parameters in vaginally born cord blood.', 'detailedDescription': 'The main purpose of the study is to understand the immediate effect of birth on immunological parameters in vaginally born cord blood and also whether mode and duration of delivery has an influence on immune parameters in cord blood.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant mothers undergoing normal vaginal delivery', 'genderDescription': 'Pregnant mothers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant mothers undergoing normal vaginal delivery\n\nExclusion Criteria:\n\n* Use of non-steroidal anti-inflammatory drugs (NSAIDs) 2 weeks prior to birth\n\n * Antenatal antibiotics treatment (2 weeks prior to birth)\n * Diabetes mellitus requiring insulin treatment during pregnancy\n * Uncontrollable Hyperthyroidism during pregnancy'}, 'identificationModule': {'nctId': 'NCT03134768', 'briefTitle': 'Effect of Birth on Immunological Parameters in Cord Blood', 'organization': {'class': 'INDUSTRY', 'fullName': 'Danone Asia Pacific Holdings Pte, Ltd.'}, 'officialTitle': 'To Investigate the Immediate Effect of Birth on Immunological Parameters in Cord Blood, and Compare With Data of CS Born Infants Collected in the JULIUS SN Study', 'orgStudyIdInfo': {'id': 'CAE.1C.D.10'}}, 'armsInterventionsModule': {'interventions': [{'name': 'This is not an interventional study', 'type': 'OTHER', 'description': 'This is an observational study'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Elena Sandalova, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Danone Asia Pacific Holdings Ltd'}, {'name': 'Anne Goh, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'KK Hospital'}, {'name': 'Mei Chin Chua, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'KK Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Danone Asia Pacific Holdings Pte, Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}